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LEVITRA Drug Profile
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Which patents cover Levitra, and what generic alternatives are available?
Levitra is a drug marketed by Bayer Hlthcare and is included in one NDA. There are two patents protecting this drug and three Paragraph IV challenges.
This drug has fifty-four patent family members in thirty-one countries.
The generic ingredient in LEVITRA is vardenafil hydrochloride. There are six drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the vardenafil hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Levitra
A generic version of LEVITRA was approved as vardenafil hydrochloride by TEVA PHARMS on May 3rd, 2012.
Summary for LEVITRA
| International Patents: | 54 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 64 |
| Clinical Trials: | 24 |
| Patent Applications: | 4,675 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for LEVITRA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LEVITRA |
| What excipients (inactive ingredients) are in LEVITRA? | LEVITRA excipients list |
| DailyMed Link: | LEVITRA at DailyMed |
Recent Clinical Trials for LEVITRA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| A2 Healthcare Taiwan Corporation | Phase 1/Phase 2 |
| Tritech Biopharmaceuticals Co., Ltd. | Phase 1/Phase 2 |
| Azienda USL Modena | Phase 2 |
Pharmacology for LEVITRA
| Drug Class | Phosphodiesterase 5 Inhibitor |
| Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Paragraph IV (Patent) Challenges for LEVITRA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| LEVITRA | TABLET;ORAL | vardenafil hydrochloride | 021400 | 2009-09-04 |
| LEVITRA | TABLET;ORAL | vardenafil hydrochloride | 021400 | 2009-07-10 |
| LEVITRA | TABLET;ORAL | vardenafil hydrochloride | 021400 | 2009-03-05 |
US Patents and Regulatory Information for LEVITRA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-003 | Aug 19, 2003 | DISCN | Yes | No | Get Started for $10 | Get Started for $10 | Get Started for $10 | ||||
| Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-004 | Aug 19, 2003 | AB | RX | Yes | Yes | Get Started for $10 | Get Started for $10 | Get Started for $10 | |||
| Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-001 | Aug 19, 2003 | AB | RX | Yes | No | Get Started for $10 | Get Started for $10 | Y | Get Started for $10 | ||
| Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-004 | Aug 19, 2003 | AB | RX | Yes | Yes | Get Started for $10 | Get Started for $10 | Y | Get Started for $10 | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for LEVITRA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-004 | Aug 19, 2003 | Get Started for $10 | Get Started for $10 |
| Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-001 | Aug 19, 2003 | Get Started for $10 | Get Started for $10 |
| Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-003 | Aug 19, 2003 | Get Started for $10 | Get Started for $10 |
| Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-001 | Aug 19, 2003 | Get Started for $10 | Get Started for $10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for LEVITRA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Ecuador | SP055541 | Get Started for $10 |
| Russian Federation | 2349306 | Get Started for $10 |
| Poland | 194801 | Get Started for $10 |
| Denmark | 1174431 | Get Started for $10 |
| >Country | >Patent Number | >Estimated Expiration |
